Recall Z-2546-2015
Covidien LLC · initiated August 19, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
Codes / lots: Lot Numbers: 516313X, 519124X, 513426X
Reason for recall
Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns
FDA-determined cause: Process control
Action taken
Medtonic/Covidien issued recall letter on August 19, 2015. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 2 Ludlow Park Drive, Chicopee, MA 01022, Attention: Field Action Returns. Contact your Medtronic representative or Customer Service at (800)-882-5878.
Details
- Recall number
- Z-2546-2015
- Initiated
- August 19, 2015
- Posted by FDA
- September 2, 2015
- Terminated
- May 24, 2017
- Product code
- DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Quantity
- 114,000 sets
- Distribution
- Nationwide Foreign: Canada Australia Denmark Germany New Zealand
- Recalling firm
- Covidien LLC, North Haven, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2545-2015 Class II | MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PCMulti-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may… | 08/19/2015Terminated |
| Z-2547-2015 Class II | Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak Preconnect System…Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may… | 08/19/2015Terminated |